9 C.F.R. PART 103—EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING
Title 9 - Animals and Animal Products
Authority: 21 U.S.C. 151–159; 7 CFR 2.22, 2.80, and 371.4.
Except as otherwise provided in this section, experimental biological products which are neither composed of nor prepared with organisms or antigens used in biologicals already licensed, shall not be prepared in the production facilities of a licensed establishment. Upon application therefor, the Administrator may authorize the preparation of experimental products on the premises of a licensed establishment if he determines that such preparation will not result in contamination of the licensed products. Each request for permission to prepare an experimental biological product on licensed premises shall indicate the nature of the unlicensed product, designate facilities to be used, and specify precautions which will be taken to prevent contamination of licensed products. Such requests shall be submitted to the Administrator. Research facilities that are entirely separate and apart from facilities used for the preparation of licensed biological products will not be considered a part of the licensed premises for purposes of this section. [30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, 1991] Safeguards as herein provided shall be established by the research investigator or research sponsor to control disposition of all animals administered experimental biological products or live organisms. (a) Surviving test animals (including challenged control animals) shall not be removed from the premises on which the tests are conducted for at least 14 days after administration of an experimental biological product or live organisms: Provided, however, That this holding period may be increased or decreased as permitted or requested by the Administrator following review of all relevant information or data available. (b) All animals administered experimental biological products which are to be slaughtered at establishments subject to the Federal Meat Inspection Act, as amended and extended (21 U.S.C. 601 et. seq.) are subject to the applicable requirements of §309.16 of this title (Meat Inspection Regulations). (c) Except as otherwise provided in this paragraph, the research investigator or research sponsor shall maintain adequate records relative to the disposition of each animal administered experimental biological products. These records shall be maintained for a minimum period of two years from the date that an experimental product was administered to such animal, and shall show the name and address of the owner; number, species, class and location of the animals; and if sold, the name and address of the consignee, buyer, commission, firm or abattoir: Provided, however, That a research investigator or research sponsor may be exempted from these recordkeeping requirements by the Administrator on the basis of acceptable data demonstrating that use of the experimental biological product will not result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter. [30 FR 11848, Sept. 16, 1965, as amended at 48 FR 57473, Dec. 30, 1983; 56 FR 66783, Dec. 26, 1991; 66 FR 21063, Apr. 27, 2001] Except as provided in this section, no person shall ship or deliver for shipment in or from the United States, the District of Columbia, or any Territory of the United States any unlicensed biological product for experimental use in animals. For the benefit of license applicants and to permit and encourage research, a person may be authorized by the Administrator to ship unlicensed biological products for the purpose of evaluating such experimental products by treating limited numbers of animals, Provided, that, the Administrator determines that the conditions under which the experiment is to be conducted are adequate to prevent the spread of disease and approves the procedures set forth in the request for such authorization. Special restrictions or tests may be imposed, especially in the case of products containing live organisms, when they are deemed necessary or advisable by the Administrator. A request for authorization to ship an unlicensed biological product for experimental study and evaluation shall be accompanied by the following: (a) One copy of a permit or letter of permission from the proper State or foreign animal health authorities of each State or foreign country involved. (b) Two copies of a tentative list of the names of the proposed recipients and quantity of experimental product that is to be shipped to each individual. In the event of subsequent changes, additional information shall be furnished when such facts are known; (c) Two copies of a description of the product, recommendations for use, and results of preliminary research work; (d) Three copies of labels or label sketches which show the name or identification of the product and bear a statement, “Notice! For Experimental Use Only—Not For Sale,” or equivalent. The U.S. Veterinary License legend shall not appear on such labels; and (e) Two copies of a proposed general plan covering the methods and procedures for evaluating the product and for maintaining records of the quantities of experimental product prepared, shipped and used. At the conclusion of field studies, results shall be obtained, summarized, and submitted to the Animal and Plant Health Inspection Service. (f) Data acceptable to the Administrator demonstrating that use of the experimental biological product in meat animals is not likely to result in the presence of any unwholesome condition in the edible parts of animals subsequently presented for slaughter. (g) A statement from the research investigator or research sponsor agreeing to furnish, upon the Administrator's request, additional information concerning each group of meat animals involved prior to movement of these animals from the premises where the test is to be conducted. Such information shall include the owner's name and address; number, species, class and location of animals involved; date shipment is anticipated; along with name and address of consignee, buyer, commission firm or abattoir. (h) Any information the Administrator may require in order to assess the product's impact on the environment. [26 FR 7726, Aug. 18, 1961, as amended at 30 FR 11848, Sept. 16, 1965; 52 FR 30131, Aug. 13, 1987; 56 FR 66783, Dec. 26, 1991]
Title 9: Animals and Animal Products
PART 103—EXPERIMENTAL PRODUCTION, DISTRIBUTION, AND EVALUATION OF BIOLOGICAL PRODUCTS PRIOR TO LICENSING
Section Contents
§ 103.1 Preparation of experimental biological products.
§ 103.2 Disposition of animals administered experimental biological products or live organisms.
§ 103.3 Shipment of experimental biological products.
§ 103.1 Preparation of experimental biological products.
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§ 103.2 Disposition of animals administered experimental biological products or live organisms.
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§ 103.3 Shipment of experimental biological products.
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